BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPARTAN RX CYP2C19 TEST SYSTEM

    K Number: K123891 · Decision Aug 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    237

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    Basic Information

    Device Name
    SPARTAN RX CYP2C19 TEST SYSTEM
    K Number
    K123891
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spartan Bioscience, Inc.
    Date Received
    December 18, 2012
    Decision Date
    August 12, 2013
    Product Code
    NTI
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTI Drug Metabolizing Enzyme Genotyping Systems

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